Abstract
Conventional egg-based vaccine manufacture has provided decades of safe and effective influenza vaccines using the technologies of the 1930–1960s. Concerns over the vulnerability of the egg supply in the case of a pandemic with a high pathogenicity avian influenza strain have spurred the development and licensure of mammalian cell culture-based influenza vaccines, the first major technological innovation in influenza vaccine since the mid-twentieth century. Mammalian cell culture provides a readily expansible, secure substrate for influenza vaccine manufacture, free from the need to suppress the bioburden associated with eggs. Most current cell culture-based vaccines still rely on seed viruses isolated in eggs. Conversion to a fully egg-free process is likely to increase the range of seed viruses available and improve the match between vaccine seed strains and circulating strains. The risk of adventitious agent introduction during manufacture in thoroughly characterized mammalian cell substrates is certainly low and probably significantly lower than the risks in egg-based manufacture. In clinical trials, cell-based influenza vaccines have proven safe and equivalent in immunogenicity to egg-based influenza vaccines. The higher containment that is possible with cell-based production proved valuable during the 2009 pandemic, when large-scale production of vaccine bulks could begin in cell culture manufacturing systems at biosafety level 3, while egg-based production was delayed, waiting for the biosafety level of the pandemic stain to be decreased. For cell-based production to replace egg-based production of influenza vaccine, the new technology will need to demonstrate its robustness over multiple strain changes and its economic competitiveness.
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I thank Giuseppe Del Giudice (Novartis Vaccines and Diagnostics) for his contribution to this chapter.
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Dormitzer, P.R. (2011). Cell Culture-Derived Influenza Vaccines. In: Rappuoli, R., Del Giudice, G. (eds) Influenza Vaccines for the Future. Birkhäuser Advances in Infectious Diseases. Springer, Basel. https://doi.org/10.1007/978-3-0346-0279-2_12
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